510(k) · Cleared
ClearedNitronox Scavenger Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parker Hannifin Corporation · CBN Apparatus, Gas-Scavenging
Cleared on Mar 5, 2023 as substantially equivalent to K080039 (G. Dundas Co.,Inc., 2008) after a 110-day review. Its family tree reaches back 2 generations to 1979.
- Decided
- Mar 5, 2023
- Review
- 110 days
- Class
- Class II
- Product code
- CBN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K790333 (1979). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K790333 | Nad Scavenging Relief Valve | Draeger Medical, Inc. | 1979 | — |
| −1 | K080039 | Passive Waste Gas Scavenger, Model 14600 | G. Dundas Co.,Inc. | 2008 | — |
| 0 (this device) | K223452 | Nitronox Scavenger Plus | Parker Hannifin Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CBN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CBN device
- #1 K193646 Dynamic Gas Scavenging System 2 (DGSS - 2)score 0.8 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080039 | Passive Waste Gas Scavenger, Model 14600Summary page 4…: Gas scavenging apparatus Regulatory Class: Class II, 21 CFR 868.5430 Product Code: CBN 5.4 Predicate Device G. Dundas Passive Waste Gas Scavenger, K080039 This predicate has not been subject to a design-related recall.… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 44 years and passes through 3 companies; a new generation was cleared every 29.1 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K080039.
How does its category compare?
All CBN devicesCBN Apparatus, Gas-Scavenging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · CBN
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CBN
Too few CBN 510(k)s in any year since 2007 to give a median.
Recalls per year · CBN
No recall names CBN since 2007.
Adverse event reports per year · CBN
1in 2025
MAUDE reports naming product code CBN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Nitronox® Scavenger Plus is intended to control the vacuum flowrate for scavenging of waste analgesic gas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223452 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223452: Nitronox Scavenger Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223452
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026